510(k) Report

Devices descending from K003154

116 later devices reach Mizar, Basis BE, Sandman Digital through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K071230Apnea Risk Evaluation System (Ares), Model 600Advanced Brain Monitoring, Inc.200743—
+1K053606BE Plus / Aura-LTM64 AmplifierEb Neuro S.P.A.20069—
+1K041198NIC36 AmplifierEb Neuro S.P.A.200410—
+1K040113Sandman SD20 AmplifierEb Neuro S.P.A.200416—
+1K031202Medipalm-20Braebon Medical Corp.200348—
+2K223676SomniCheckBrainmatterz, LLC20230—
+2K121996BE Plus LTM Amplifier Gwi AmplifierEb Neuro S.P.A.20123—
+2K111314Morpheus OXWidemed, Ltd.20110—
+2K083577Harmonie SystemStellate Systems201101
+2K110705Apnea Risk Evaluation System (Ares)Advanced Brain Monitoring, Inc.201141—
+2K103140Nicolet Wireless EegCarefusion 209, Inc.201171
+2K101691Lifelines Photic StimulatorLifelines, Ltd.20103—
+2K090957Blackrock Neuroport Biopotential Signal Processing SystemI2s Micro Implantable Systems, LLC2009132
+2K073682Embletta GoldEmbla Systems, Inc.2008411
+2K071782Micromed Brain Spy Plus, Embia Titanium DevicesMicromed S.P.A.20084—
+2K061764Medibyte, Model MP8Braebon Medical Corp.20060—
+2K050919Lifegard II Family Multi-Function Patient Monitor, Models AN4320, AN4320P, AN4321P…Analogic Corp.20050—
+3K251366EEG-1260A Neurofax System (EEG-1260A); JE-940A EEG Amplifier Unit (JE-940A); LS-940A…Nihon Kohden Corporation20250—
+3K242305BE Plus PRO, Neurotravel LIGHTEb Neuro S.P.A.20240—
+3K211974LED PHOTIC SystemMicromed S.P.A.20210—
+3K202174Digital NeuroPort Biopotential Signal Processing SystemBlackrock Microsystems20210—
+3K173936Natus Photic StimulatorNatus Medical Incorporated Dba Excel-Tech Ltd. (Xltek)20180—
+3K171384Micromed BRAIN QUICK systemMicromed S.P.A.201801
+3K171397Sienna Ultimate Wireless AmplifierEms Handels Gesellschaft M.B.H.20170—
+3K170441ElectroTekMobilemedtek201712
+3K162681Enobio Wireless EEGNeuroelectrics Barcelona S.L.U.20171—
+3K151600R-40 EEG AmplifierLifelines, Ltd.20151—
+3K133517Nemus 2 SystemEb Neuro S.P.A.20141—
+3K122196Cervello Bio-Potential Signal Acquistion System Product FamilyBlackrock Neuromed, LLC20133—
+3K122516Embletta MPREmbla Systems2013271
+3K111194Apnea Risk Evaluation System (Ares)Advanced Brain Monitoring, Inc.201140—
+3K092003CPC Sleep Data Recorder, Model M1, and Application SoftwareMyCardio, LLC20094—
+3K090273Kai Sensors Non-Contact Respiratory Rate Spot Check, Model 100, Kai Rspot, Model 100Kai Sensors, Inc.20097—
+4K261604Enobio Dx (Enobio Dx 8);Enobio Dx (Enobio Dx 20);Enobio Dx (Enobio Dx 32)Neuroelectrics Barcelona S.L.U.20260—
+4K242832NExT Station; NExT Station AdvancedEb Neuro S.P.A.20240—
+4K212788Seer HomeSeer Medical Pty, Ltd.202201
+4K210593Onera Sleep Test System (Onera STS)Onera B.V.20223—
+4K203343Wesper LabWesper, Inc.20211—
+4K172271Trackit T4 EEG AmplifierLifelines, Ltd.20180—
+4K163696SleepImage SystemMycardio, LLC Dba Sleepimage.20173—
+4K160499Apnea Risk Evaluation System (ARES), Model 620Watermark Medical20170—
+4K161579Watch-PAT200UItamar Medical, Ltd.201720—
+4K151940Thora-3Di, Model T-01Pneumacare Limited20163—
+4K133995Neuron-Spectrum-4/P with Neuron-Spectrum.Net SoftwareNeurosoft, Ltd.20151—
+4K112514Apnea Risk Evaluation System (Ares)Advanced Brain Monitoring, Inc.201238—
+4K103631Sleepminder Breathing Frequency IndicatorBiancamed Limited20111—
+4K100773Kai Spot Model KMS 200Kai Medical, Inc.20100—
+5K260050WRAP SystemHuneo, LLC20260—
+5K242001Philips VSC-MEDlibPhilips Medical Systems Nederland B.V.20252—
+5K223573Onera Sleep Test System (Onera STS)Onera B.V.20231—
+5K221816Wesper LabWesper, Inc.20230—
+5K220254Neuron-Spectrum-AM with Neuron-Spectrum.NET SoftwareNeurosoft, Ltd.20220—
+5K203839WatchPAT200U (WP200U)Itamar Medical, Ltd.20224—
+5K200445The C100 Contactless Breathing MonitorCircadia Technologies, Ltd.20200—
+5K191031NightOwlEctosense NV20205—
+5K182618SleepImage SystemMycardio, LLC Dba Sleepimage.20192—
+5K180775Watch-PAT300Itamar Medical, Ltd.201812—
+5K140190Night ShiftAdvanced Brain Monitoring, Inc.20141—
+5K130007Sleep ProfilerAdvanced Brain Monitoring, Inc.201314—
+5K130013X4 SystemAdvanced Brain Monitoring, Inc.201317—
+5K120450Sleep ProfilerAdvanced Brain Monitoring, Inc.201216—
+5K120447X4Advanced Brain Monitoring, Inc.201218—
+6K252628CassieWesper, Inc.20260—
+6K243220Onera STS 2 (ONERA STS 2)Onera B.V.20250—
+6K242224Happy Health Home Sleep TestHappy Health, Inc.20250—
+6K243966FaceHeart Vitals Software Development Kit (FH vitals SDK-RR)Faceheart Corp.20251—
+6K231355AuroraEnsodata20240—
+6K231546SomfitCompumedics Limited20231—
+6K222331WatchPAT300 (WP300)Itamar Medical, Ltd.20223—
+6K213463NightOwlEctosense NV20213—
+6K183559WatchPAT ONEItamar Medical, Ltd.20195—
+6K180608Lunoa SystemNightbalance BV20180—
+6K153412Sleep ProfilerAdvanced Brain Monitoring, Inc.201613—
+6K152040X8 System - Sleep Profiler (SP40), X8 System - Sleep Profiler PSG2 (SP29), X8 System -…Advanced Brain Monitoring, Inc.20151—
+6K142825ZmachineConsolidated Research of Richmond, Inc.20150—
+6K131383X10 Headset with X-Series Basic Software, X24 Headset with X-Series Basic SoftwareAdvanced Brain Monitoring, Inc.201314—
+7K253650Anura Mobile Core SDK (M1)Nuralogix Corporation20260—
+7K252383Somfit DCompumedics Limited20250—
+7K233403Flexset SystemZeto, Inc.20241—
+7K233438SleepStageMLBeacon Biosignals, Inc.20240—
+7K223675WatchPAT ONE (WP1)Itamar Medical, Ltd.20232—
+7K220095ANNE SleepSibel, Inc.20224—
+7K213007Cerebra Sleep SystemCerebra Medical, Ltd.20220—
+7K220028NightOwlEctosense NV20222—
+7K200705Nurochek SystemCryptych Pty, Ltd.20200—
+7K182227Esprit NovaNeurozone Msh Incorporated20190—
+7K172735WR19 SystemZeto, Inc.20183—
+7K170138NeuronauteBioserenity20170—
+7K162627EnsoSleepEnsodata, Inc.20179—
+7K141316Cognision Eeg/EP SystemNeuronetrix Solutions20157—
+8K260455New Wave SystemZeto, Inc.20260—
+8K253668Onera SleepMap (SLEEPMAP)Onera B.V.20260—
+8K250460WatchPAT400 (WP400)Itamar Medical, Ltd.20251—
+8K250058NEAT 001Brain Electrophysiology Laboratory Company, LLC20250—
+8K243268TipTraQ (TTQ001)Pranaq Pte., Ltd.20250—
+8K240285Huxley SANSA Home Sleep Apnea Test (1000-00)Huxley Medical20243—
+8K223922Somnum (V.1.1.2.)Honeynaps Co., Ltd.20231—
+8K222579Belun Sleep System BLS-100Belun Technology Company Limited20230—
+8K221179SomnoMetryNeumetry Medical, Inc.20223—
+8K220056iSyncWaveiMediSync, Inc.20220—